A study of 5-aminolevulinic acid with radiotherapy (radiodynamic therapy) for patients with first recurrence of glioblastoma brain tumor

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What is this study about?

This study focuses on patients with recurrent glioblastoma, which is a type of brain tumor that has returned after initial treatment. The study tests a new treatment approach called radiodynamic therapy (RDT), which combines a medication called 5-Aminolevulinic acid (given as an oral solution) with radiation therapy.

The treatment involves taking Gliolan (the brand name for 5-Aminolevulinic acid) by mouth in combination with radiation therapy sessions. The main goal of this research is to determine the highest safe dose of the medication that can be given repeatedly during radiation therapy treatment without causing unacceptable side effects.

During the study, participants will receive different doses of the medication along with radiation therapy over a four-week period. The treatment schedule will be carefully monitored to evaluate how well patients tolerate the combination therapy and to assess any side effects that may occur. This includes monitoring for any effects on neurological function and skin reactions.

1 Initial medical evaluation

A medical assessment will confirm the presence of recurrent glioblastoma (a type of brain tumor that has returned after initial treatment)

Laboratory tests will check liver function, kidney function, and blood clotting

For women of childbearing age, a pregnancy test must be completed within 72 hours before starting treatment

2 Treatment preparation

The treatment combines two elements: 5-Aminolevulinic acid (5-ALA) medication and radiation therapy

The medication comes as Gliolan 30 mg/ml powder that will be prepared as a solution to take by mouth

The treatment plan will be scheduled over a 4-week period

3 Radiation therapy sessions

You will receive radiotherapy treatments over 4 weeks

The radiation will be delivered to specific areas using focused beams

The oral medication will be given according to a schedule determined by your medical team

4 Monitoring during treatment

Regular checks will monitor for any side effects

Special attention will be paid to neurological and skin reactions

Any new symptoms or side effects rated as moderate or severe will be documented

5 Safety precautions

You must use effective contraception during the entire study and for 6 months afterward

Male patients must use condoms during treatment and for 90 days after

Avoid sun exposure and bright lights during treatment period due to potential skin sensitivity

Who Can Join the Study?

  • Must be at least 18 years old
  • Must provide written informed consent after receiving comprehensive information about the study
  • Must have recurrent glioblastoma in the upper part of the brain after initial surgery and treatment, including second or third recurrences
  • Must have histological confirmation (examination of tissue under microscope) of recurring glioblastoma
  • Must have a Karnofsky Performance Score of 60 or higher (a measure of ability to perform daily activities)
  • Must have adequate kidney function:
    – Creatinine less than 3 times the normal limit
    – eGFR (kidney filtration rate) of 60 ml/min or higher
  • Must have adequate liver function:
    – Bilirubin less than 1.5 times the normal limit
    – Liver enzymes (ALT and AST) less than 3 times the normal limit
  • Must have normal blood clotting values as determined by the doctor
  • For women who can become pregnant: must have a negative pregnancy test within 72 hours before starting treatment
  • Both men and women who can have children must use highly effective contraception during the study and for at least 6 months after the last treatment

Who Cannot Join the Study?

  • Prior history of radiotherapy (radiation treatment) to the brain within the last 12 months
  • Presence of other active cancers requiring treatment
  • Severe allergic reactions to 5-ALA (a drug used in the study)
  • Pregnancy or breastfeeding
  • Inability to undergo MRI scans (magnetic resonance imaging) due to metal implants or claustrophobia
  • Serious heart, liver, or kidney problems
  • Current participation in other clinical trials
  • Use of medications that could interfere with the study treatment
  • Inability to give informed consent
  • History of porphyria (a rare genetic condition affecting blood production)
  • Severe psychological or psychiatric conditions
  • Active infection requiring treatment
  • Immunosuppression (weakened immune system) from any cause
  • Life expectancy less than 3 months
  • Known hypersensitivity to study medications

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Uqzpmanrlqxfvzfcvnuad Mcyqlqth Arg Munster Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
16.10.2024

Trial locations

5-Aminolevulinic acid (5-ALA) is a naturally occurring compound used in photodynamic therapy. In this trial, it is used as part of radiodynamic therapy for brain tumors. When taken orally, this medication accumulates in cancer cells and becomes activated by radiation, helping to target and destroy tumor cells more effectively. This makes the cancer cells more sensitive to radiation treatment while aiming to minimize damage to surrounding healthy tissue.

Radiodynamic therapy (RDT) is a combination treatment that uses both 5-Aminolevulinic acid and radiation therapy. This approach combines the medication with targeted radiation to create a potentially more effective treatment for recurrent glioblastoma, a type of brain cancer.

Glioblastoma – A type of brain cancer that forms in the supportive tissue of the brain and typically grows rapidly. It begins with symptoms such as headaches, personality changes, nausea, and seizures. The tumor forms from star-shaped brain cells called astrocytes and can appear in any part of the brain. Glioblastoma often creates increased pressure in the brain as it grows, leading to various neurological symptoms. The tumor can affect different brain functions depending on its location, including movement, speech, thinking, and sensation.

Trial ID:
2024-517651-12-00
Trial Phase:
Human Pharmacology (Phase I) – Other

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